Assessment of PrEP and PEP furnishing in San Francisco Bay Area pharmacies; an observational cross-sectional study.

BACKGROUND: Over 1 million people in the US are infected with human immunodeficiency virus (HIV). As of 2021, pharmacists in California can prescribe PrEP and PEP without establishing a collaborative practice agreement in an effort to reduce HIV transmission. However, in 2021 less than 3% of independent pharmacies in the San Francisco Bay Area did so. To our knowledge, there has been no follow-up research assessing potential changes in PrEP/PEP furnishing rates in the region. OBJECTIVE: Assess the extent of PrEP/PEP furnishing in San Francisco Bay Area pharmacies 3 years after policy implementation. METHODS: We conducted an observational, cross-sectional study to identify independent community and mail-order pharmacies furnishing PrEP/PEP in the 9-county San Francisco Bay Area in 2024. Furnishing pharmacies were identified via phone calls and the findings were validated with in-person visits. We also identified the number of retail chain pharmacies furnishing PrEP/PEP in San Francisco County. RESULTS: We contacted 202 independent community and mail order pharmacies in the 9-county San Francisco Bay Area by telephone; of these, 16 reported furnishing PEP/PrEP and all confirmed their ability to furnish when visited in person. We contacted 67 retail chain pharmacies in San Francisco County; of these, 11 pharmacies reported furnishing PrEP/PEP (10 Safeway; 1 Walgreens). CONCLUSIONS: More pharmacies furnished PrEP/PEP in the 9-county San Francisco Bay Area in 2024 (8%) than in 2021 (3%); in addition, one retail chain pharmacy had instituted a furnishing protocol. However, furnishing rates remained low. Past research suggests that advertising and the development of furnishing protocols may help increase furnishing and increase medication access.

Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects.

The availability of high-quality skin test allergens is a prerequisite for the reliable diagnosis of occupational type I allergies. Due to the withdrawal of existing marketing authorizations (MAs) by pharmaceutical companies and the lack of new MAs for commercial test allergens, there is an increasing diagnostic gap in Germany and other EU member states, which makes it necessary to investigate alternative ways of providing in vivo diagnostics. The German Medicinal Products Act (Arzneimittelgesetz = AMG) allows for the possibility of preparing medicinal products in pharmacies without the need for an MA or a manufacturing authorization pursuant to Section 13 (2) No. 1 in conjunction with Section 13 (2a) Sentence 2 No. 3 AMG. This also includes test allergens. In addition to the AMG, the requirements of the German Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung - ApBetrO) and the European Pharmacopoeia apply in particular. Medicolegal and practical challenges, as well as potentials of manufacturing skin prick test solutions in public pharmacies are presented based on examples of different allergen source materials.

Questionnaire on the Current Status and Awareness of Palliative Medicine by Community Cooperation Pharmacies.

Community cooperation pharmacies are equipped to prepare narcotics and sterile injectable drugs for palliative medicine at home for cancer pain and end-of-life care; however, to the best of our knowledge, the actual status of the system to provide palliative medicine at home has not yet been examined. Therefore, in this study, given that home palliative medicine is one of the accreditation criteria for community cooperation pharmacies, a questionnaire survey was conducted among managing pharmacists engaged in community cooperation pharmacies to investigate the actual status of the system to provide appropriate services, mainly pain management, to patients who need home palliative medicine. An analysis of responses to the questionnaire showed that pharmacists working in community cooperation pharmacies had a high level of understanding of the proper use of rescue doses of medical narcotics and patient guidance. Pharmacists with experience in sterile and injection preparations also had a high level of understanding of palliative medicine. On the other hand, they had a low level of understanding of the WHO method for cancer pain treatment and appropriate suggestions for opioid switching. These results indicate that the creation of learning opportunities, such as training on injectables and prescription designs, for pharmacists in community cooperation pharmacies is one of the measures that may improve their understanding of palliative medicine.

Effectiveness of eHealth Interventions in Improving Medication Adherence Among Patients With Cardiovascular Disease: Systematic Review and Meta-Analysis.

BACKGROUND: Nonadherence to medication among patients with cardiovascular diseases undermines the desired therapeutic outcomes. eHealth interventions emerge as promising strategies to effectively tackle this issue. OBJECTIVE: The aim of this study was to conduct a network meta-analysis (NMA) to compare and rank the efficacy of various eHealth interventions in improving medication adherence among patients with cardiovascular diseases (CVDs). METHODS: A systematic search strategy was conducted in PubMed, Embase, Web of Science, Cochrane, China National Knowledge Infrastructure Library (CNKI), China Science and Technology Journal Database (Weipu), and WanFang databases to search for randomized controlled trials (RCTs) published from their inception on January 15, 2024. We carried out a frequentist NMA to compare the efficacy of various eHealth interventions. The quality of the literature was assessed using the risk of bias tool from the Cochrane Handbook (version 2.0), and extracted data were analyzed using Stata16.0 (StataCorp LLC) and RevMan5.4 software (Cochrane Collaboration). The certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. RESULTS: A total of 21 RCTs involving 3904 patients were enrolled. The NMA revealed that combined interventions (standardized mean difference [SMD] 0.89, 95% CI 0.22-1.57), telephone support (SMD 0.68, 95% CI 0.02-1.33), telemonitoring interventions (SMD 0.70, 95% CI 0.02-1.39), and mobile phone app interventions (SMD 0.65, 95% CI 0.01-1.30) were statistically superior to usual care. However, SMS compared to usual care showed no statistical difference. Notably, the combined intervention, with a surface under the cumulative ranking curve of 79.3%, appeared to be the most effective option for patients with CVDs. Regarding systolic blood pressure and diastolic blood pressure outcomes, the combined intervention also had the highest probability of being the best intervention. CONCLUSIONS: The research indicates that the combined intervention (SMS text messaging and telephone support) has the greatest likelihood of being the most effective eHealth intervention to improve medication adherence in patients with CVDs, followed by telemonitoring, telephone support, and app interventions. The results of these network meta-analyses can provide crucial evidence-based support for health care providers to enhance patients' medication adherence. Given the differences in the design and implementation of eHealth interventions, further large-scale, well-designed multicenter trials are needed. TRIAL REGISTRATION: INPLASY 2023120063; https://inplasy.com/inplasy-2023-12-0063/.

Expanding Public Health Initiatives Through Community Pharmacies and Student Pharmacists: A Programmatic Case Study.

BACKGROUND: Community pharmacies are critical to the public health infrastructure in the United States and provide reliable information for public health concerns. Public health agencies curate educational materials that community pharmacy teams can disseminate. Student pharmacists participate in experiential learning at community pharmacies which could be utilized for dissemination of these resources. OBJECTIVES: The objectives of this project were to: (1) design a model for dissemination of public health information at community pharmacies; and (2) evaluate both the dissemination model's reach within communities and student pharmacist learnings from engagement in the model. METHODS: We engaged student pharmacists in a model to disseminate information at community pharmacies for two Centers for Disease Control and Prevention initiatives about Opioid Use Disorder Anti-Stigma and Antibiotic Stewardship Education. The number of pharmacies and student pharmacists who participated from 2021-2023 were retrospectively reviewed to demonstrate programmatic reach. A retrospective text mining of student assignments was conducted to evaluate student experiences. Descriptive statistics were used to report quantitative data. An inductive, rapid content analysis was completed for qualitative data. RESULTS: Across three years, 333 student pharmacists participated. Students reached 121 community pharmacies, 139 practicing pharmacist preceptors, and over 2000 patients with education and resources. Eleven student learning points emerged from the qualitative analysis. These included learnings around opioid use disorder and antibiotic stewardship. Students also acknowledged that there are public health needs present in communities and that community pharmacy teams are well-positioned to address these needs. CONCLUSION: Engaging student pharmacists to distribute curated information from public health authorities, to both pharmacist preceptors and patients at community pharmacies, is one way to educate future pharmacists, pharmacy teams, and communities on public health priorities. Pharmacies can serve as key venues in communities for dissemination of reliable public health information.

Comparing methadone policy and practice in France and the US: Implications for US policy reform.

Despite being among the most effective treatments for opioid use disorder, methadone is largely unavailable in the United States, due primarily to federal and other policies that limit its availability and regulate clinical decisions about doses, visit frequency, and drug testing. There is unprecedented momentum to change decades-old US methadone policies. Yet uncertainty remains as to whether reforms will be adopted and how policies will be implemented. France has among the best methadone access and lowest overdose death rates worldwide. 87 % of French people with opioid use disorder receive methadone or buprenorphine, versus an estimated 13-20 % in the US. France's opioid-related overdose rates are far lower than the US. This article compares French and US systems, including current and proposed US policies, and underscores potential implications for US policymakers. In France, methadone can be initiated in specialty addiction settings and hospitals, with subsequent handoff to primary care. Methadone can be dispensed in community pharmacies and filled like other opioids, without requirements for supervised dosing. Decisions about visit frequency, medication doses, and drug testing are governed by clinical best practices and patient-clinician shared decision-making. In the US, methadone for opioid use disorder is regulated unlike any other medication (including methadone for pain) and is governed by strict federal controls, including from law enforcement and healthcare. With few exceptions, methadone for opioid use disorder is only available in Opioid Treatment Programs. US clinicians cannot prescribe methadone for opioid use disorder. Federal rules determine minimum visit frequency, initial dose limits, and other conditions of treatment, which states may further limit. Policies assert strong influence on patient experience, treatment access, and health outcomes. Despite being less restrictive than the US, the French model includes limits designed to avoid or minimize potential harms. French policies have important implications for potential US reforms.

Awareness of the rational use of medicines and the medication counseling practice in community pharmacies in Nyamagana district, Mwanza: A cross-sectional study.

Background: Community pharmacies play a vital role in promoting the rational use of medicines by providing medication counseling to their clients to ensure the safe and appropriate use of medicines. Thus, this study aimed to assess awareness of the rational use of medicines and the medication counseling practice in community pharmacies. Methods: A descriptive cross-sectional study was conducted from June to July 2021. The study was carried out in community pharmacies in Nyamagana district, Mwanza, Tanzania. Data were collected using a self-administered, semi-structured questionnaire. The data for descriptive statistics were entered in Microsoft Excel and analyzed using STATA version 15. Results: A total of 68 pharmaceutical personnel participated in this study. Thirty-eight participants, that is, 55.9%, were aware of the rational use of medicines. The awareness was significantly influenced by the participant's age and profession. The majority of the dispensers practiced rational use of medicines by telling their clients the dose of the medicine (n = 63, 92.6%), frequency of administration (n = 61, 89.7%), and route of administration (n = 60, 88.2%). However, only 21 (30.9%) told clients about the need to comply with their medications. The information that was not regularly provided by dispensers to clients was the side effects of medicines (n = 6, 8.8%). Less than a quarter of participants frequently told their clients information regarding why the medicine is prescribed, drug interactions, storage conditions, and contraindications. Conclusion: This study has shown that almost half of the participants were aware of the rational use of medicines. There was a low frequency at which information was given regarding medication compliance, side effects, storage conditions, drug interactions, and contraindications. These findings underscore the need for targeted interventions to enhance pharmaceutical personnel's understanding of rational use of medicine principles and improve their practice of patient medication counseling.

Awareness of rational medicine use and medication counseling practices in community pharmacies Why was the study done? Community pharmacies play a vital role in promoting the rational use of medicines by providing medication counseling to their clients to ensure the safe and appropriate use of medicines. Thus, this study aimed to assess awareness of the rational use of medicines and the medication counseling practice in community pharmacies. What did the researchers do? This study was conducted from June to July 2021. The study was carried out in community pharmacies in Nyamagana district, Mwanza, Tanzania. Data were collected using a questionnaire. What did the researchers find? A total of 68 pharmaceutical personnel participated in this study. Thirty-eight participants were aware of the rational use of medicines. The majority of the dispensers practiced rational use of medicines by telling their clients the dose of the medicine (n = 63), frequency of administration (n = 61), and route of administration (n = 60). What do the findings mean? These findings highlight the need for targeted interventions to enhance pharmaceutical personnel's understanding of rational use of medicine principles and improve their practice of patient medication counseling.

Counselling with a focus on product and price transparency for over-the-counter headache medicines: A simulated patient study in community pharmacies in Munich, Germany.

BACKGROUND: In Germany, over-the-counter (OTC) medicines may only be dispensed by community pharmacies (CPs). German CPs must ensure 'adequate' counselling, including the cost of medicines. Along with information gathering and advice giving as classic aspects of counselling, the aim was also to investigate counselling indicators of product and price transparency. METHODS: The cross-sectional study was based on the covert simulated patient (SP) methodology and was conducted in a random sample of CPs stratified by districts in the major German city of Munich. Each of the 178 selected CPs was visited once by one of five trained female students. They simulated a symptom-based sub-scenario 1 with a request for an OTC medicine for a headache and a sub-scenario 2 with standardised information regarding product and price transparency. The assessment, completed immediately postvisit by the SPs, included a total of 23 items. RESULTS: All 178 scheduled visits were completed successfully. The median counselling score with the classic items was 3.0 out of 12 points (interquartile range [IQR] 4.25) and when expanded by items for product and price transparency the score was 4.0 out of 14 points (IQR 4.00). A selection of medicines was offered unsolicited in 38.2% of the visits and in 5.6% of the visits voluntary price information was provided before the transaction. A request for a cheaper medicine led to a significant price reduction (Wilcoxon signed-rank test; p < 0.001, r = 0.869). CONCLUSION: Due to the below-average level of counselling, the regional chambers of pharmacists are recommended to initiate measures for improvement. There is also potential for optimisation with regard to product and price transparency as an important extension of the classic counselling aspects. It is therefore recommended that the government raise customers' awareness of the cost of medicines.

Automated Non-Sterile Pharmacy Compounding: A Multi-Site Study in European Hospital and Community Pharmacies with Pediatric Immediate Release Propranolol Hydrochloride Tablets.

Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend® excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies.

Current Perspectives, Practices, and Barriers Faced by Community Pharmacists Regarding Pharmaceutical Care Services for Diabetes Mellitus in the United Arab Emirates.

Background: Providing accurate and sufficient information is a crucial requirement for delivering effective diabetes care, making it essential for community pharmacists to possess adequate knowledge of diabetes mellitus (DM) and its management. Objective: To investigate community pharmacists' level of expertise and engagement in providing counseling and health promotion services for individuals with DM in the United Arab Emirates (UAE). Methods: A cross-sectional study design was used. The community Pharmacies were chosen via random sampling and researchers then conducted face-to-face interviews with them using the structured questionnaire. The questionnaire included demographic data, 14 questions on the knowledge and 9 questions about the practice concerning pharmaceutical care for Diabetes Mellitus. Results: The average age ± SD was 31 ± 6.3. Of the total 516 community pharmacists recruited in the study, 37.2% (n=192) were male and 62.8% (n=324) were female. The average knowledge score about DM prevention and management was 9.7 with a 95% confidence interval (CI) [9.5, 9.9] and the average practice score about DM prevention and management was 7.1 with a 95% confidence interval (CI) [6.9, 7.2]. Better knowledge scores were observed in chief pharmacists (OR 1.29; 95% CI 1.08-1.56), pharmacists with 6-10 Years of experience (OR 6.92; 95% CI 3.43-8.86), pharmacist with > 10 years of experience (OR 1.99; 95% CI 1.67-2.36), when the number of patients the pharmacist serve is 5-10 (OR 1.27; 95% CI 1.06-1.53) and being trained on DM prevention and management (OR 2.18; 95% CI 1.92-2.47). Similarly, better practice scores were observed in older participants (OR1.02; 95% CI 1.001-1.03), chain pharmacies (OR 1.42; 95% CI 1.20-1.68), chief pharmacists (OR 1.56; 95% CI 1.18-2.06), when the number of patients the pharmacists serve was 5-10 (OR 12.26; 95% CI 7.26-16.19), when the number of patients the pharmacists serve was 11-20 (OR 4.23; 95% CI 3.54-5.06) and being trained on DM prevention and management (OR 1.33; 95% CI 1.11-1.59). The most commonly reported barriers to providing counseling and health promotion services for diabetes mellitus (DM) in community pharmacies include a lack of coordination with other healthcare professionals (77%) and insufficient knowledge or clinical skills (68.7%). Conclusion: Our study revealed that community pharmacy staff members displayed a noteworthy level of involvement in providing pharmaceutical care services for patients with diabetes mellitus. Based on these findings, it is recommended to enhance pharmacy education by incorporating more advanced, evidence-based training and curricula focusing on disease management and appropriate therapies, particularly for diabetes.

Understanding individual experiences with stick-built and modular cleanrooms: Lessons learned and a call to action.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: The purpose of this study was to assess the real-world experiences of cleanroom managers and specialists who have designed, installed, and maintained stick-built and/or modular cleanrooms, delineate the advantages and disadvantages of each type of cleanroom, and gather sterile compounding cleanroom design and installation advice and lessons learned. METHODS: This study was conducted via surveys and semistructured interviews of individuals with cleanroom experience in the previous 5 years. Qualitative analyses were conducted on participants' survey and interview responses to assess their satisfaction with each type of cleanroom and to determine what they perceive to be the pros and cons of each type based on their own experiences. Key lessons learned and advice from these individuals were also extracted from their survey and interview responses. RESULTS: Fourteen individuals from 13 US states completed the survey; twelve participated in follow-up interviews. Fifty percent of the participants (n = 7) had installed 5 or more cleanrooms in the previous five years and over half (n = 8; 57%) had 7 or more years of cleanroom experience. The average satisfaction scores for each type of cleanroom, on a 1 to 10 scale, was 5.3 for stick-built (n = 11) and 9.3 for modular (n = 4). The pros of stick-built cleanrooms included greater design and material flexibility and lower up-front costs. The pros of modular cleanrooms included the cleanroom experience and expertise of modular vendors, quick and easy installations, guaranteed certification, and high-quality and durable design features and materials. Additionally, modular cleanrooms had fewer long-term maintenance issues, greater long-term flexibility, and lower indirect and long-term costs than stick-built cleanrooms. Key pieces of advice from the participants included the following: do your homework before beginning a cleanroom project; make sure heating, ventilation, and air conditioning system(s) and air handlers are adequate for your needs; and remember that the ultimate purpose of a quality cleanroom is patient safety. Participants also advocated for industry-wide cleanroom standards that go beyond USP regulations. CONCLUSION: The findings of this study confirm many of the purported pros and cons of each type of cleanroom, with further insight gained into the relative quality and costs of each type. Modular cleanrooms were considered by most participants to be a better long-term option, based on quality and lifetime costs, if feasible to install. Study participants also emphasized that designing and installing pharmacy cleanrooms is a complex and time-intensive process that often comes with a steep learning curve. While there are federal and state cleanroom standards available and consultants for hire, a comprehensive resource or manual that could provide guidance, insight, and collective lessons learned on cleanroom design and installation is needed.

Patient Satisfaction With Public Pharmacy Services: Structural and Policy Implications From Greece.

Objectives This study aimed at investigating patient satisfaction with services offered by a certain type of public pharmacies in Greece (National Organisation for Healthcare Provision (EOPYY) pharmacies), tasked with dispensing mostly high-cost drugs, in an effort to highlight the aspects to be optimized. Methods  The Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (PSPSQ 2.0) questionnaire was the main instrument of our research. We received 201 full responses from patients themselves and patients' companions who had visited EOPYY pharmacies in Athens, the capital city of Greece, from October 2022 to January 2023. Results  Patients seem satisfied with public pharmacies in general. In fact, the professionalism of the pharmacists, the respect that patients have received from them, and the information and explanations that were given by pharmacists, received a very high score. On the other hand, the parameters referred to the information that patients received from pharmacists for the overall improvement of their health had the lowest score, revealing an apparent lag in the field of medicinal advice. Conclusion  Without any doubt, patients expect their pharmacists to be more guiding and to better communicate this role. This requires more time to be spent with patients, focused training, teamwork, layout, and other organizational interventions.

User Experience of Persons Using Ingestible Sensor-Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study.

Background: A digital health technology's success or failure depends on how it is received by users. objectives: We conducted a user experience (UX) evaluation among persons who used the Food and Drug Administration-approved Digital Health Feedback System incorporating ingestible sensors (ISs) to capture medication adherence, after they were prescribed oral pre-exposure prophylaxis (PrEP) to prevent HIV infection. We performed an association analysis with baseline participant characteristics, to see if "personas" associated with positive or negative UX emerged. Methods: UX data were collected upon exit from a prospective intervention study of adults who were HIV negative, prescribed oral PrEP, and used the Digital Health Feedback System with IS-enabled tenofovir disoproxil fumarate plus emtricitabine (IS-Truvada). Baseline demographics; urine toxicology; and self-report questionnaires evaluating sleep (Pittsburgh Sleep Quality Index), self-efficacy, habitual self-control, HIV risk perception (Perceived Risk of HIV Scale 8-item), and depressive symptoms (Patient Health Questionnaire-8) were collected. Participants with ≥28 days in the study completed a Likert-scale UX questionnaire of 27 questions grouped into 4 domain categories: overall experience, ease of use, intention of future use, and perceived utility. Means and IQRs were computed for participant total and domain subscores, and linear regressions modeled baseline participant characteristics associated with UX responses. Demographic characteristics of responders versus nonresponders were compared using the Fisher exact and Wilcoxon rank-sum tests. Results: Overall, 71 participants were enrolled (age: mean 37.6, range 18-69 years; n=64, 90% male; n=55, 77% White; n=24, 34% Hispanic; n=68, 96% housed; and n=53, 75% employed). No demographic differences were observed in the 63 participants who used the intervention for ≥28 days. Participants who completed the questionnaire were more likely to be housed (52/53, 98% vs 8/10, 80%; P=.06) and less likely to have a positive urine toxicology (18/51, 35% vs 7/10, 70%; P=.08), particularly methamphetamine (4/51, 8% vs 4/10, 40%; P=.02), than noncompleters. Based on IQR values, ≥75% of participants had a favorable UX based on the total score (median 3.78, IQR 3.17-4.20), overall experience (median 4.00, IQR 3.50-4.50), ease of use (median 3.72, IQR 3.33-4.22), and perceived utility (median 3.72, IQR 3.22-4.25), and ≥50% had favorable intention of future use (median 3.80, IQR 2.80-4.40). Following multipredictor modeling, self-efficacy was significantly associated with the total score (0.822, 95% CI 0.405-1.240; P<.001) and all subscores (all P<.05). Persons with more depressive symptoms reported better perceived utility (P=.01). Poor sleep was associated with a worse overall experience (-0.07, 95% CI -0.133 to -0.006; P=.03). Conclusions: The UX among persons using IS-enabled PrEP (IS-Truvada) to prevent HIV infection was positive. Association analysis of baseline participant characteristics linked higher self-efficacy with positive UX, more depressive symptoms with higher perceived utility, and poor sleep with negative UX.

Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya.

BACKGROUND: In Africa, the delivery of HIV pre-exposure prophylaxis (PrEP) at public healthcare clinics is challenged by understaffing, overcrowding, and HIV-associated stigma, often resulting in low PrEP uptake and continuation among clients. Giving clients the option to refill PrEP at nearby private pharmacies, which are often more convenient and have shorter wait times, may address these challenges and improve PrEP continuation. METHODS: This mixed methods study used an explanatory sequential design. At two public clinics in Kiambu County, Kenya, clients ≥ 18 years initiating PrEP were given the option to refill PrEP at the clinic where they initiated for free or at one of three nearby private pharmacies for 300 Kenyan Shillings (~ $3 US Dollars). The providers at these pharmacies (pharmacists and pharmaceutical technologists) were trained in PrEP service delivery using a prescribing checklist and provider-assisted HIV self-testing, both with remote clinician oversight. Clients were followed up to seven months, with scheduled refill visits at one, four, and seven months. The primary outcomes were selection of pharmacy-based PrEP refills and PrEP continuation. Following pilot completion, 15 in-depth interviews (IDIs) with clients who refilled PrEP were completed. We used descriptive statistics and thematic analysis to assess study outcomes. RESULTS: From November 2020 to November 2021, 125 PrEP clients were screened and 106 enrolled. The majority (59%, 63/106) of clients were women and the median age was 31 years (IQR 26-38 years). Over 292 client-months of follow-up, 41 clients (39%) refilled PrEP; only three (3%) at a participating pharmacy. All clients who completed IDIs refilled PrEP at clinics. The reasons why clients did not refill PrEP at pharmacies included: a preference for clinic-delivered PrEP services (i.e., pre-existing relationships, access to other services), concerns about pharmacy-delivered PrEP services (i.e., mistrust, lower quality care, costs), and lack of knowledge of this refill location. CONCLUSIONS: These findings suggest that clients who initiate PrEP at public clinics in Kenya may have already overcome barriers to clinic-delivered PrEP services and prefer PrEP access there. To reach new populations that could benefit from PrEP, a stand-alone model of pharmacy-delivered PrEP services may be needed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04558554 [registered: June 5, 2020].

Pharmacist-implemented intervention to surmount COVID-19 vaccination hesitancy in adults with substance use disorders.

PURPOSE: Substance use disorders (SUDs) increase the risk and severity of infectious diseases, including coronavirus disease 2019 (COVID-19). Adults with a co-occurring SUD and psychiatric disorder were studied to elucidate the association between SUD severity and (1) COVID-19 vaccination status, (2) receptivity to a one-session intervention with a pharmacist advocating the benefits of vaccination, and (3) acceptance of referral for vaccination following the intervention. METHODS: COVID-19 vaccination status was recorded in 460 adults with SUD (324 males and 136 females) upon entry into inpatient treatment. A 2-parameter item response theory (IRT) model quantified SUD severity. Pharmacist-delivered intervention, modeled after the screening, brief intervention, and referral to treatment (SBIRT) protocol, was offered to unvaccinated participants. RESULTS: Higher SUD severity was associated with a lower vaccination rate. Nicotine, opioid, and sedative use disorders were most frequently associated with unvaccinated status. SUD severity was not associated with receptivity to intervention advocating vaccination or subsequent acceptance of a referral for vaccination. The portion of the sample that received the intervention was over 7 times more likely to accept a referral for vaccination when compared to participants who rejected the intervention (20.8% vs 2.8%). CONCLUSION: Pharmacist-administered intervention produced motivation for vaccination in a number of recipients; however, receptivity to the intervention was not related to SUD severity.

Factor Analysis of Patients Who Find Tablets or Capsules Difficult to Swallow Due to Their Large Size: Using the Personal Health Record Infrastructure of Electronic Medication Notebooks.

BACKGROUND: Understanding patient preference regarding taking tablet or capsule formulations plays a pivotal role in treatment efficacy and adherence. Therefore, these preferences should be taken into account when designing formulations and prescriptions. OBJECTIVE: This study investigates the factors affecting patient preference in patients who have difficulties swallowing large tablets or capsules and aims to identify appropriate sizes for tablets and capsules. METHODS: A robust data set was developed based on a questionnaire survey conducted from December 1, 2022, to December 7, 2022, using the harmo smartphone app operated by harmo Co, Ltd. The data set included patient input regarding their tablet and capsule preferences, personal health records (including dispensing history), and drug formulation information (available from package inserts). Based on the medication formulation information, 6 indices were set for each of the tablets or capsules that were considered difficult to swallow owing to their large size and concomitant tablets or capsules (used as controls). Receiver operating characteristic (ROC) analysis was used to evaluate the performance of each index. The index demonstrating the highest area under the curve of the ROC was selected as the best index to determine the tablet or capsule size that leads to swallowing difficulties. From the generated ROCs, the point with the highest discriminative performance that maximized the Youden index was identified, and the optimal threshold for each index was calculated. Multivariate logistic regression analysis was performed to identify the risk factors contributing to difficulty in swallowing oversized tablets or capsules. Additionally, decision tree analysis was performed to estimate the combined risk from several factors, using risk factors that were significant in the multivariate logistic regression analysis. RESULTS: This study analyzed 147 large tablets or capsules and 624 control tablets or capsules. The "long diameter + short diameter + thickness" index (with a 21.5 mm threshold) was identified as the best indicator for causing swallowing difficulties in patients. The multivariate logistic regression analysis (including 132 patients with swallowing difficulties and 1283 patients without) results identified the following contributory risk factors: aged <50 years (odds ratio [OR] 1.59, 95% CI 1.03-2.44), female (OR 2.54, 95% CI 1.70-3.78), dysphagia (OR 3.54, 95% CI 2.22-5.65), and taking large tablets or capsules (OR 9.74, 95% CI 5.19-18.29). The decision tree analysis results suggested an elevated risk of swallowing difficulties for patients with taking large tablets or capsules. CONCLUSIONS: This study identified the most appropriate index and threshold for indicating that a given tablet or capsule size will cause swallowing difficulties, as well as the contributory risk factors. Although some sampling biases (eg, only including smartphone users) may exist, our results can guide the design of patient-friendly formulations and prescriptions, promoting better medication adherence.

Availability of Dispensing and Storage Facilities at Public and Community Pharmacies at Bahir Dar and Gondar Towns.

Background: The availability of various facilities that aid in providing expected services is necessary for the practice of pharmacy, which aims to make the best use of medications and other healthcare products and services. Therefore, the aim of this study was to assess the availability of dispensing and storage facilities at public and community pharmacies in Bahir Dar and Gondar towns. Methods: In Gondar and Bahir Dar towns' public and private pharmacies, a facility-based cross-sectional study was conducted from July 2023 to September 2023. All pharmacy areas that were open during data collection were included in the study. The frequency and percentage were calculated using descriptive statistics. Results: From 239 pharmacies, 208 (87.0%) of them were open during data collection, and they are included in the study. The water supply and dispensing counter were available in the dispensing area in 79.3% and 60.1% of instances, respectively. They also had adequate room for storage (92.8%), dispensing (92.8%), and receiving (95.7%) of medicines. Additionally, about 98.1% of the facilities had shaded, ventilated, and dry areas. A therapeutic order was the most often used method (59.6%) for medication organization. Merely 1.9% of participants did not employ a strategy to arrange their medications. A refrigerator (88.0%), a refrigerator thermometer (91.3%), a spoon or spatula (81.3%), a separate storage facility (74.5%), a cold room (68.8%), a lockable cabinet (90.9%), a tablet counter (69.2%), and a fire extinguisher (safety device) (88%) were among the various storage equipment the majority of the pharmacies in the survey had. Nonetheless, air conditioning was absent from the majority (53.4%) of pharmacy facilities. Conclusion: Few pharmacies need to make improvements to their facilities in order to encourage convenient drug storage and dispensing practices, even though the majority of the pharmacies surveyed had all the necessary equipment and infrastructure. In addition to initiating the pharmacies to provide good practices of dispensing and storage, facility-focused initiation and regulation should be obtained to ensure full availability of the facilities.

A Roadmap for Using Causal Inference and Machine Learning to Personalize Asthma Medication Selection.

Inhaled corticosteroid (ICS) is a mainstay treatment for controlling asthma and preventing exacerbations in patients with persistent asthma. Many types of ICS drugs are used, either alone or in combination with other controller medications. Despite the widespread use of ICSs, asthma control remains suboptimal in many people with asthma. Suboptimal control leads to recurrent exacerbations, causes frequent ER visits and inpatient stays, and is due to multiple factors. One such factor is the inappropriate ICS choice for the patient. While many interventions targeting other factors exist, less attention is given to inappropriate ICS choice. Asthma is a heterogeneous disease with variable underlying inflammations and biomarkers. Up to 50% of people with asthma exhibit some degree of resistance or insensitivity to certain ICSs due to genetic variations in ICS metabolizing enzymes, leading to variable responses to ICSs. Yet, ICS choice, especially in the primary care setting, is often not tailored to the patient's characteristics. Instead, ICS choice is largely by trial and error and often dictated by insurance reimbursement, organizational prescribing policies, or cost, leading to a one-size-fits-all approach with many patients not achieving optimal control. There is a pressing need for a decision support tool that can predict an effective ICS at the point of care and guide providers to select the ICS that will most likely and quickly ease patient symptoms and improve asthma control. To date, no such tool exists. Predicting which patient will respond well to which ICS is the first step toward developing such a tool. However, no study has predicted ICS response, forming a gap. While the biologic heterogeneity of asthma is vast, few, if any, biomarkers and genotypes can be used to systematically profile all patients with asthma and predict ICS response. As endotyping or genotyping all patients is infeasible, readily available electronic health record data collected during clinical care offer a low-cost, reliable, and more holistic way to profile all patients. In this paper, we point out the need for developing a decision support tool to guide ICS selection and the gap in fulfilling the need. Then we outline an approach to close this gap via creating a machine learning model and applying causal inference to predict a patient's ICS response in the next year based on the patient's characteristics. The model uses electronic health record data to characterize all patients and extract patterns that could mirror endotype or genotype. This paper supplies a roadmap for future research, with the eventual goal of shifting asthma care from one-size-fits-all to personalized care, improve outcomes, and save health care resources.